What are the compliance requirements for digital therapy?
Digital therapy must adhere to regulations like HIPAA in the U.S., ensuring patient data privacy and security.
How do these regulations affect the development of digital therapy apps?
Developers must implement strict data protection measures and ensure their apps are secure to meet compliance standards.
Are there specific certifications needed for these apps?
Yes, certifications like CE marking in Europe or FDA approval in the U.S. may be required depending on the app's claims.
What are the consequences of non-compliance?
Non-compliance can lead to legal penalties, loss of trust, and potential shutdown of the service.
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